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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device

Micro Therapeutics Inc, Dba Ev3 Neurovascular: Embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of the device delivery system remains in the patient. If a Pipeline Flex embolization device has already been implanted successfully, there is no increased risk to patients due to this issue.

Agency Publication Date: March 9, 2020
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Affected Products

Product: ev3 Pipeline Flex Embolization Device. For neurological endovascular use.

Lots: A920066 A920068 A920069 A920070 A920071 A920072 A920073 A920074 A920075 A920076 A920078 A920079 A921354 A921355 A921356 A921357 A921358 A921359 A921360 A921361 A921362 A921363 A922016 A922017 A922018 A922020 A922021 A922022 A922480 A922481 A922483 A922484 A922571 A922572 A922575 A923951 A923956 A923959 A923960 A923963 A923967 A923968 A923969 A924193 A924194 A924197 A924198 A924199 A924638 A924640 A924641 A924642 A924643 A924644 A924645 A924646 A924647 A924648 A924650 A927827 A927828 A927829 A927830 A927831 A927832 A927833 A927834 A927835 A927836 A927837 A927838 A927839 A927840 A927841 A927842 A927843 A927844 A927845 A927847 A927848 A929704 A929705 A929706 A929707 A929708 A929710 A929711 A929713 A929714 A929716 A929717 A929893 A929894 A929896 A929897 A929898 A929901 A929902 A929903 A929904 A929906 A929907 A932604 A932605 A932607 A932609 A932610 A932611 A932612 A932613 A933706 A933707 A933709 A933710 A933781 A933782 A933783 A933784 A933785 A933786 A933787 A933788 A933789 A934499 A934500 A934503 A934504 A934505 A934506 A935182 A935184 A937237 A937238 A937239 A937240 A937241 A937645 A937646 A937647 A937648 A937649 A937650 A937651 A937652 A937653 A937654 A938289 A938290 A938291 A938293 A939611 A941306 A941307 A941308 A941309 A941310 A942157 A942159 A942160 A942161 A942162 A942163 A942164 A942165 A942166 A944241 A944242 A944244 A944245 A944246 A944247 A944249 A944250 A944251 A944253 A944254 A944255 A944256 A944257 A945204 A945205 A945438 A945441 A945445 A945447 A945450 A945451 A945452 A945454 A945455 A946808 A946811 A946813 A946815 A946816 A946817 A947150 A947151 A947152 A947153 A947154 A947155 A947396 A947397 A947398 A947399 A947400 A947401 A947402 A947403 A947405 A947407 A947408 A948123 A948124 A948125 A948126 A948127 A948128 A948129 A948130 A948131 A949486 A949487 A949488 A949489 A949490 A949491 A949492 A949493 A949494 A949495 A949496 A949497 A950324 A950329 A950332 A950333 A950335 A950337 A950341 A950344 A950346 A950753 A950754 A950945 A950946 A950947 A952499 A952500 A953289 A953290 A953291 A953292 A953294 A953295 A953296 A953297 A955938 A955939 A955940 A955943 A955944 A955945 A955946 A955947 A955948 A956502 A956504 A956505 A956506 A956507 A956508 A956509 A956510 A956511 A956512 A957173 A957175 A957176 A957270 A957271 A957272 A957273 A957274 A957282 A957461 A957470 A957472 A957473 A957475 A957476 A957477 A957478 A957479 A957480 A957481 A957483 A957484 A957485 A957486 A957488 A957490 A957492 A958533 A958534 A958535 A958536 A958537 A958538 A958539 A958540 A958542 A958543 A958547 A959339 A959341

Product: ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.

Lots: A918616 A918617 A918618 A918619 A918620 A918621 A918622 A918623 A918624 A918625 A918626 A918628 A918665 A918667 A918668 A920902 A922597 A922598 A922599 A922600 A922601 A922687 A922688 A922690 A922691 A922692 A922693 A922694 A922695 A922697 A922698 A922699 A925289 A925290 A925291 A925292 A925293 A925295 A925296 A925297 A925298 A925299 A925300 A925913 A925914 A925915 A925917 A925918 A925920 A925923 A925926 A925928 A925929 A925930 A925931 A926530 A926531 A926532 A926533 A926536 A926537 A926538 A926625 A926626 A926627 A926628 A926629 A927960 A927961 A927962 A931450 A931451 A931452 A931453 A931454 A931455 A931456 A931458 A931459 A931460 A934805 A934806 A934807 A934808 A934809 A935480 A935481 A935482 A935483 A935484 A935486 A935487 A935900 A935901 A935902 A935903 A935904 A935912 A935913 A935914 A935916 A935917 A936513 A936514 A936515 A936516 A936517 A936518 A936519 A936520 A936522 A936523 A936524 A937232 A937233 A937234 A937235 A937236 A937242 A937655 A938294 A938295 A938296 A938297 A938298 A938299 A938301 A939100 A939101 A939103 A939104 A939137 A939138 A939139 A939140 A939142 A939143 A939144 A939145 A939146 A939148 A939151 A939154 A939612 A939613 A939614 A939615 A939616 A939617 A939618 A939619 A939620 A939621 A939622 A939623 A939624 A939625 A939626 A939627 A939628 A939629 A939630 A939632 A941401 A941403 A941404 A941405 A941406 A941407 A941409 A941410 A941411 A941415 A941417 A942167 A942168 A943052 A943053 A943054 A943056 A943219 A943220 A943222 A943321 A943322 A943324 A943326 A943672 A943674 A943676 A943677 A943678 A943680 A943682 A943683 A943684 A943686 A945206 A945207 A945208 A945209 A945210 A946108 A946109 A946110 A946591 A946592 A948115 A948116 A948117 A948118 A948119 A948120 A948121 A948122 A950755 A950756 A950757 A950758 A950759 A950760 A950941 A950942 A950943 A950944 A952144 A952145 A952146 A952147 A952148 A952149 A952150 A952153 A952154 A952155 A952156 A952157 A952483 A952484 A952485 A952486 A952487 A952488 A952489 A952490 A952491 A952497 A952498 A952684 A952685 A952686 A952687 A952688 A952689 A952690 A952692 A952693 A952694 A952695 A952696 A952697 A953298 A953919 A953920 A953921 A953922 A953924 A953925 A953926 A953927 A953929 A953930 A954177 A954178 A954180 A954181 A954182 A954185 A954186 A954187 A954188 A954189 A954190 A954191 A954192 A954193 A954194 A954195 A954514 A954515 A954516 A954518 A954519 A954520 A954521 A954522 A954523 A954524 A954525 A954526 A954527 A954528 A954529 A954530 A954531 A954532 A954533 A954534 A954535 A954793 A954794 A954795 A954796 A954797 A954798 A954799 A954801 A954802 A954803 A954804 A954805 A954807 A954809

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85069
Status: Resolved
Manufacturer: Micro Therapeutics Inc, Dba Ev3 Neurovascular
Manufactured In: United States
Units Affected: 2 products (1050; 762)
Agency Last Updated: September 9, 2020

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.